Feasibility and Smokers' Reactions to DNA Feedback

Smoking Clinical Trial

Official title:

Feasibility and Smokers' Reactions to DNA Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922790
• Other study ID #: Pro00075612
• Status: Completed
• Phase: N/A
• First received: September 26, 2016
• Last updated: January 4, 2018
• Start date: February 14, 2017
• Est. completion date: July 24, 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid) damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.

Description:

The study aims to recruit 50 smokers who are not engaged in quitting. The study will involve two in-person visits. During visit 1, participants will complete a baseline survey and have their blood drawn. Approximately two weeks later, in visit 2, smokers will be randomized in a 1:2:2 ratio to one of three arms:

1. education about harms of smoking (control group);

2. same education plus information on DNA damage and biomarker feedback (biomarker arm) without visual of damage; or

3. same as arm 2 except accompanied with visuals of participants' normal and DNA damage cells. Participants in the this arm will be informed of their proportion of leucocytes showing DNA damage with pictures of their normal and damaged cells.

The goal of the analyses is to obtain effect size estimates (direction, confidence intervals) to inform if results align with hypotheses and obtain insights about reactions about the feedback (Aim 1). The study will collect feasibility data from baseline to three months (e.g., percentage who show up to the sessions, attrition).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 24, 2017
• Est. primary completion date: July 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ages 18+

• smoke > 5 cig/day during the last week

• be open to biomarker feedback

• not actively trying to quit

Exclusion Criteria:

• smoker carbon monoxide level(CO < 10 ppm)

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• standard health information
Subjects will review standard health information
• standard health information plus info. on DNA damage
Subjects will review standard health information and information on DNA damage
• Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage
Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of participant understanding of materials, to be measured by a survey	Study will measure the extent to which the biomarker information was understood, as measured by a survey	week 3
Primary	Percentage of subjects who show up to the sessions	Study will collect feasibility data on how many participants come to each visit.	Week 1
Primary	Extent to which participants believe the feedback to be accurate	The study will measure the extent to which DNA damage results would be considered accurate using a survey.	week 3
Primary	Degree of participant understanding of materials, to be measured by an interview	Study will measure the extent to which the biomarker information was understood, as measured by an interview.	Week 3
Primary	Percentage of subjects who show up to the sessions	Study will collect feasibility data on how many participants come to each visit.	Week 3
Primary	Extent to which participants believe the feedback to be trustworthy	The study will measure the extent to which DNA damage results would be considered trustworthy using a survey.	Week 3
Primary	Extent to which participants believe the feedback to be accurate	The study will measure the extent to which DNA damage results would be considered accurate using an interview.	Week 3
Primary	Extent to which participants believe the feedback to be trustworthy	The study will measure the extent to which DNA damage results would be considered trustworthy using an interview.	Week 3
Secondary	Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on	Change in coherence, as measured by likert scale	Baseline to 3 months
Secondary	Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on	Change in risk appraisals, as measured by a scale	Baseline to 3 months
Secondary	Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on	Change in motivation to quit, as measured by a motivation to quit scale	Baseline to 3 months
Secondary	Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on	Change in action planning, as measured by number of participants who have made a plan to quit smoking	Baseline to 3 months
Secondary	Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention	Mean levels of smoking at 3 months	3 months
Secondary	Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention	Number of quit attempts at 3 months	3 months
Secondary	Effect size of the quit rate between the control and biomarker arm at three months post-intervention	Quit rate at 3 months	3 months